Required Education:

• Bachelor's degree in engineering required.

Preferred Education:

• Bachelor's degree in biomedical engineering or mechanical engineering.

Required Qualifications/Skills/Experience:

• 4+ years of industry experience in Quality Engineering, Quality Assurance, Quality Control, or a related engineering function.
• 4+ years of experience applying engineering rationale to independently make decisions.
• 4+ years of strong problem-solving and critical-thinking experience.
• 2+ years of experience with equipment and/or process validation.
• Experience supporting EU-MDR programs.
• Knowledge of Change Management and Quality Management System (QMS) principles.
• Experience with First Article Inspection (FAI) strategy, execution, and approvals.
• Experience with Production Part Approval Process (PPAP).
• Experience supporting change control and change impact assessments.
• Experience with validation, testing, inspection, process control, and process improvement.
• Ability to work independently with minimal supervision and exercise professional judgment.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent written and verbal English communication skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to manage multiple priorities in a fast-paced environment.
• Ability to work effectively as part of a multi-site team.
• Ability to collaborate cross-functionally and act as the voice of Quality.
• Up to 10% travel may be required.

Preferred Qualifications/Skills/Experience:

• Medical device industry experience.
• Strong knowledge of

ISO 13485.

• Knowledge of EU Regulations related to medical devices.
• Knowledge of GDP and GMP concepts.
• Experience with Quality Risk Management.
• Knowledge of statistical concepts and risk-based methodologies.
• Experience with SOP development, review, and updates.
• Experience with Risk Management documentation.
• Experience leading quality improvement initiatives and projects.

Senior Quality Engineer Overview:

The Senior Quality Engineer provides quality engineering support across quality assurance, quality control, preventative activities, operations, and other business functions. This role focuses on ensuring products meet quality and regulatory requirements through process control, validation, inspection, testing, risk management, and continuous improvement.

The position is an individual contributor role requiring independent judgment, engineering expertise, and the ability to make decisions based on established procedures, professional experience, and quality principles. The engineer will also lead or support quality initiatives and cross-functional projects while ensuring compliance with applicable regulations and standards.

Job Duties:

• Develop and execute First Article Inspection (FAI) strategies and obtain required approvals.
• Support PPAP activities and documentation.
• Perform change control activities and change impact assessments.
• Support equipment and process validation activities.
• Develop, review, and update SOPs and Quality documentation.
• Support Risk Management activities and documentation.
• Develop and implement methods for process control, improvement, testing, and inspection.
• Identify and prevent product/process defects and quality issues.
• Support quality assurance, quality control, and preventative activities within operations.
• Lead or support quality improvement initiatives and projects.
• Apply engineering and quality principles to investigate problems and determine appropriate actions.
• Collaborate with engineering, operations, and other cross-functional teams.
• Ensure quality processes comply with applicable regulations, standards, and QMS requirements.
• Advocate for Quality during cross-functional discussions and decision-making.
• Work independently while managing multiple priorities and deliverables.
• Participate in multi-site team activities and travel up to 10% as required.
• Only those lawfully authorized to work in the designated country associated with the position will be considered.
• Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client's business needs and requirements.

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